Early Growth Response 1 (Egr) Fish Probe Kit

OWK · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.6040

Classification

FDA Product Code: OWK
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.6040
Review panel: PA
Medical specialty: Immunology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

The egr1 fish probe kit is intended to detect deletion of the lsi egr1 probe target in bone marrow specimens and may be used, in addition to cytogenetics, other biomarkers, morphology, and other clinical information, at the time of diagnosis as an aid in determining the prognosis of acute myeloid leukemia (aml) patients.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown